Luer protection pouch and luer valve/male luer protection method

ABSTRACT

A medical swab pouch is disclosed. The inexpensive elastic pouch contains disinfectant and is configured for protecting and swabbing a wide variety of luer systems to prevent and eliminate bacterial contamination. The pouch has a flattened configuration and can be elastically dilated, as by squeezing the pouch between the thumb and index finger and is readily carried in large numbers in nurse&#39;s pockets (in a manner similar to that for conventional alcohol swabs). The pouch covers and protects the luer valve at the discretion of the user and without transmission of torsion or longitudinal force which might loosen the luer valve or otherwise be transmitted to the vein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-part of U.S. Patent ApplicationSer. No. 11/724,888 filed Mar. 16, 2007 now U.S. Pat. No. 7,794,675,U.S. Patent Application Ser. No. 11/801,649 filed May 10, 2007 and U.S.Patent Application Ser. No. 11/805,381 filed May 23, 2007 which claimpriority of Provisional Application 60/782,913 filed Mar. 16, 2006,Provisional Application 60/836,637, filed Aug. 9, 2006, and ProvisionalApplication 60/900,536, filed Feb. 8, 2007 the contents of each of whichare incorporated by reference as if completely disclosed herein.

BACKGROUND AND SUMMARY OF THE INVENTION

Medical patient access devices and access systems allow access to theinterior of the patient (such as the vascular system) to deliver a fluidor a pharmaceutical. However, the movement of potentially deadlymicroorganisms into patient's interior through such access devices andsystems has long been a major problem. Bacteria and yeast may gain entryinto a patient's vascular system from access ports during the connectionof the port to deliver the fluid or pharmaceutical. In fact each accessoccurrence into an access portal is associated with at least some riskof comprising a “Microorganism Transmitting Event” (MTE). The bacterialor yeast bolus associated with a MTE can comprise a single organism orgreater than 1000 organisms. While most MTEs are without consequence,each MTE poses a risk of causing clinical bacteremia which is associatedwith severe morbidity, increased hospital expense and/or death. The riskof each MTE is related to the vulnerability of the patient and thepathogenicity and sensitivity of the organism transmitted. Factors whichgreatly amplify the risk posed by a given MTE are a low WBC count, thepresence of prosthetic heart valves or joints, and malnutrition, to namea few. Regardless of the vulnerability of the patient, once clinicalbacteremia is established, the death rate is relatively high.Microorganisms are becoming more resistant to antibiotics and patientsare often living longer with more prosthetic components and thereforethe risk posed by MTEs to patients will likely continue to increase overthe next few decades.

Throughout the sequence of procedures associated with an access eventthere are many risks of contact or droplet nuclei contamination whichcan contribute to MTEs. Contamination can occur during drug mixing,attachment of a cannula, and insertion into the access portal. Becausethe access procedure is so common and simple, the risk associated withentry into fluid connection with a patient's vascular system has oftenbeen overlooked. Presently the risk to hospitals and patients is asubstantial function of diligence of the employee performing theaccesses and this diligence is largely uncontrollable. When substantialmorbid and mortal risk in association with a high number of routineprocedures is defined as a primary function of the diligence of aheterogeneous population of employees, a substantial degree ofunnecessary injury to patients will inevitably result The presentinventor contends that it is unacceptable for hospitals to performhundreds of thousands of accesses to patient's vascular system withoutcontrolling all of the controllable risks associated with the accessprocedure.

It is the purpose of the present invention to provide a system andmethod which allows control of the risk along that all portions of themedication mixing delivery process such that drug mixing can beperformed at the bedside within a predictably sterile enclosure andpatient protecting components such as the biocidal septum and cannulasystem with or without a antiseptic cover are used so that substantiallyall of the controllable risks are controlled.

One purpose of the present invention is to reduce global morbidity andmortality related to access worldwide by reducing the contamination riskassociated with drug mixing, reduce the risk associated with eachaccess, and finally to reduce the number of accesses themselves.

It is important to understand the dynamics of access relatedtransmission events. For this purpose several useful terms will beintroduced. The present inventor defines the “MTE Magnitude” as thenumber of transmitted organisms associated with a given MTE. The peak,the variability and distribution, and the aggregate MTE Magnitude values(such as the mean MTE Magnitude per 100 access events) are all relevant.The present inventor defines the “MTE %” as the percentage of accessevents which are associated with MTEs. Because access devices differ instructure and function, each access device type differs both withrespect to the MTE % and at least one value indicative of the MTEMagnitude. The risk of clinical bacteremia and death due to a MTE is adirect function of 3 primary factors. The MTE Magnitude, thepathogenicity of the organisms transmitted, and the patient's state ofvulnerability. Finally, the risk of severe sepsis induced morbidityand/or death due to an access device is a direct function 4 primaryfactors, the MTE Magnitude, the MTE %, the pathogenicity of theorganisms transmitted, and the patient's state of vulnerability. Thefirst two of those factors are exquisitely dependent on the design ofthe access device.

Given the complexity defining the risks associated with a given accessevent, the addition of new uncontrolled risk associated with a less thandiligent worker in the performance of a diligence dependent accessprocedure is unacceptable. Since worker diligence can never bereasonably assured, it is one of the purposes of the present inventionto provide a much more “diligence independent access procedure”.

In many environments and medical settings cleansing immediately prior toaccess is not reliably performed, therefore even if it is possible tocomprehensively clean an access device and thereby achieve low the MTE %and MTE Magnitude values for a given device in a carefully performedclinical trial, this approach would not reflect the likely real worldimpact of that access device on global mortality. In addition the effectof even a single missed cleaning event prior to access may have agreater impact on certain access device types. While a missed cleaningevent prior to access may have little effect on one device type (otherthan perhaps to cause a single MTE event to occur during the accesswhich occurred without the cleansing), the same single missed cleaningevent may severely contaminate the interior of another device type. Forexample, the interstitial dead spaces of open piston valves, which isjuxtaposed the fluid opening, are not accessible to cleaning. For thisreason, even a single event of failure to cleanse the access surface ofan open piston valve prior an access event may contaminate theincubating interstitial spaces of an open piston valve early in its useand therefore may potentially cause a rapid rise in both MTE % and MTEMagnitude as the organisms incubate inside the valve over the next 72hours (long after the initial uncleansed access occurred). The presentinventor designates this feature of some access devices as “accessinduced irreversible incubation”. Conventional access device designs inwide use today which exhibit a functional propensity for irreversibleincubation will not stand the test of time.

In the real world a mix of cleansed and uncleansed accesses commonlyoccur. Since cleansing is not universally practiced, a combination ofboth the cleansed and uncleansed MTE % and MTE Magnitude values reflectthe real word risk of morbidity and death related to access. In additionthe effect of early internal contamination on internal incubation andrising MTE % and MTE Magnitude should be evaluated if the true risk of agiven device is to be reasonably assessed.

The present inventor proposes that the annual number of deaths worldwideassociated with access devices is given by formula 1. The implicationsof this simple formula are profound and formula 1 should be consideredcarefully by every designer of access devices. D=A1(R1)+A2(R2) . . .+An(Rn)1. Where: [0011] D=the number of sepsis deaths per year due toaccess events [0012] A1=the number of accesses events per year fordevice 1 [0013] R1=the mean risk of death per access event for device 1[0014] n=the number of different access devices in the worldwide marketR1 is a direct function at least one MTE magnitude value for accessdevice 1. Of course the value R for any access device cannot be knownwith the evidence available today and even for the most dangerous accessdevices, R will be extremely small. However, worldwide millions ofaccess events are performed every day. For this reason very smalldifference in MTE % and/or MTE Magnitude between widely deployed devicescan translate into major differences in access device related mortality.Perhaps the most subtle implications of formula 1 is that minor designfeatures which subtly favor microorganism transmission or even amodestly inferior design type with exhibits the propensity forirreversible incubation may have a major impact on the access relateddeath rate worldwide. Also because any R is vastly amplified in patientswith low WBC or when the organism is highly pathogenic and resistant(such as Vancomycin Resistant Staphlococcus Aureus), a modestly inferiordesign may appear quite safe in one population but be highly dangerousto other populations.

The above relationship clearly shows that the global death rateassociated with access devices can be reduced by reducing the number ofaccess events or by developing new devices with a lower MTE % and MTEMagnitude values especially if these are low for both cleansed anduncleansed accesses. An access device which has low MTE % and MTEMagnitude values in both the cleansed and uncleansed state is describedby the present inventor as comprising an “anti-infective access device”.It is the one purpose of the present invention to reduce the globaldeath rate related to access events by providing an anti-infectiveaccess device which achieves; a reduction in number of access events, areduction in the MTE % and MTE Magnitude, less dependency on cleansing,and high resistance to irreversible contamination and incubation.

According to one aspect of the present invention an access system isprovided which does not protect or incubate microorganisms in exposedregions juxtaposed the fluid path. With devices which lack this feature,such as the open piston valves (like the Clave), bacteria (and othermicroorganisms) often first gain access to crevices and spaces along orwithin the access system from environmental contamination, thehealthcare worker, or from the skin or excretions of the patient. Thebacteria often propagate in these crevices and spaces producing aprotective biofilm. Often, portions of these residing bacteria, with orwithout supporting biofilm, can be displaced into the lumen of theaccess device. This displacement is commonly mechanical and induced bythe insertion of a solid member such as a male luer into the device.Once displaced, the bacteria are then readily carried by the solidmember or by fluid flow into the patient where they can cause deathespecially in patients with low white blood cell counts or internalprosthetic devices. Each time a conventional access device is enteredfrom the outside the risk to the patient is increased. Typical accesssystems include, for example luer valves, ports, stopcocks, catheter andtubing mounted septum, hollow receivers, introducers, catheters,manifolds, hubs with extension sets, and open tubing connection systemsto name a few. The term access systems is extended herein to includesystems which receive a medical implement and which contain medicalagents for insertion into a patient or for receipt of fluid from withina patient body such as drug vials, IV bags, pressure monitoring systems,and urinary bags to name a few. Access systems generally have interiorportions for receiving medical implements, for example male luers,needles, biopsy devices, retrieval devices, catheters, and stents toname a few. Access systems also usually include at least one interiorlumen to receive fluid or to store fluid.

In an example, access systems which comprise the luer receiving hubs ofIV catheters and Y sites are particularly vulnerable because they may beentered with external male luers up to 10 or more times a day. Often theluer is contaminated during use but this contamination is invisible sothat the luer is stored in a cap and reused. Research performed at theCenter for Disease Control and Prevention clearly demonstrated thatpiston luer valves have internal walls, which can allow growth of vastnumbers of deadly bacteria.

FIG. 1 shows a piston luer valve of the prior art with the exposedcircumferential crevice into which bacteria can gain access to a regionof incubation. The straight arrow points to the circumferential creviceat the face of the device, which connects directly with the internalwalls of the valve (curved arrow). FIG. 3 is a photo of a pair of pistonluer valves of the prior art, showing how the male luer is connected tothe upper face of the piston luer valve (region of both the straight andcurved arrow of FIG. 1). Once the bacteria gain access the inner surfaceof the piston luer valves biofilm can attach to the inner surface. Toillustrate, FIG. 3 is an electron micrograph of bacteria and biofilm onthe inner surface of a piston luer valve of FIG. 2 taken during a studyby the Centers for Disease Control and Prevention in Atlanta Ga.,(Donlan et al., Journal of Clinical Microbiology, February 2001, p.750-753, Vol. 39, No. 2.). The article is incorporated herein byreference and provides additional background for the present invention.

The problem with at least some of the piston luer valves has become anincreasingly recognized problem with published outbreaks. Indeed, when apatient in 2006 with an indwelling IV catheter develops a fever, thephysician must promptly consider the piston luer valve as the potentialsource of the infection and replace it if there is any question as towhether or not the luer valve has been colonized internally.

Another problem relates to contamination and/or colonization ofimplements (such as the luer tip) between insertions into the accessdevice. For example, during intermittent piggyback infusions, it isdesirable to store the male luer in a sterile environment between uses.The problems associated with the storage of medical implements betweenuses are also discussed in U.S. Pat. No. 5,167,643 of the presentinventor (the contents of which are incorporated by reference as ifcompletely disclosed herein). This patent provides additional backgroundfor the present invention. Although capping and docking the luer tip canprovide a component of protection from the environment, the tip end andouter sidewall of the male luer is often already contaminated withbacteria before recapping therefore the cap can actually act as anincubator. Bacteria actually can reach the luer tip from the accessdevice itself. In fact, during use, the tip (including the outersidewall of the tip) of the male luer as in FIG. 2 actually resideswithin the previously discussed circumferential crevice and adjacent thesidewall (FIG. 1) of the piston luer valve.

The present inventor has witnessed marked visible contamination of aluer tip, which was withdrawn from a open piston luer valve of the typeshown in FIG. 2 in use in the intensive care unit. If this contaminationhad not been visible and the male luer stored in a conventional cap,this contamination might well have been displaced into the patient withthe next connection. Most of the time the contaminating microorganismsare not associated with visible biofilm. So that the organisms arecommonly carried directly into the caps and/or valve where they canproliferate and cause death.

Indeed, both the biofilm and the bacteria within the circumferentialcrevice can become attached to the male luer tip and then be carried tothe site of storage (such as within a new sterile cap). In this case theinterior of the new cap will now become contaminated by the outside ofthe male luer and the organisms can then propagate on the male luer tipand within the cap between accesses. Since caps are commonly reused andmay contain fluid from the luer, the cap, which is supposed to act as a“luer protector”, can actually function as an incubator for bacteriaduring and between connections with the access device. As is evidentfrom this discussion, the problem is profound because the systeminterconnects between the implement, the cover for the implement, andthe access device. Once a reservoir for bacterial growth is allowed todevelop within an access device, the cover, or the medical implementitself, the organism can produce a trail of contaminating movement toall connecting components of the system.

As discussed in U.S. Pat. No. 6,171,287 of the present inventor (thecontents of which are incorporated by reference as if completelydisclosed herein), structural complexity as a function of spaces betweeninternal moving parts, and especially exposed crevices which connect tointernal rigid components can greatly increase the risk of colonization.However, even with the elimination of these crevices, bacteria can stillinvade access systems. One approach has been to add an anti-infectivechemical agent to access devices as coatings, impregnations, or fillingfluid. However this approach is often less than optimally effectivebecause biofilm, indwelling fluid, or distance may protect the organismfrom diffusion of the agent. Also the bacteria or yeast may developresistance to the chemical agent or the patient or an incompatible drugmay react to the agent. Another approach commonly is to increase theeducation of the need to scrub the surface with disinfectant.Unfortunately, as is evident from a review of FIG. 1, thecircumferential crevice of piston luer valves of the type discussedabove is not accessible to scrubbing. Many of these types of devices aremanufactured with opaque outer sidewalls hiding the circumferentialcrevice so even the presence of blood and other nutrients within thecrevice are not visible to the healthcare worker. The outside of thedevice may be scrubbed and look pristine while the inside is loaded withnutrients and bacteria, which the healthcare worker cannot see.Furthermore, this approach is unreliable as the healthcare worker may bedistracted, or operating in an emergent environment with otherpriorities. The education approach does not solve the inherent weaknessof the access device and places the health of the patient at the mercyof the unpredictable diligence of the potentially highly distractedhealthcare worker.

One of the primary problems associated with access devices such as theluer valve is the failure of healthcare workers to scrub or otherwiseprep the surface of the septum. At the least, healthcare workers wouldbenefit from a reminder to scrub the surface before accessing the valve.

One embodiment of the present invention comprises a connection systemcomprising; a elastomeric septum defining an outer face, a cannula,which can be a male luer, having a distal end and defining at least onedistal opening for flowing fluid out of the cannula, the openingdefining at least one wall side wall facing the opening, the opening andthe septum face being configured to minimize the contact of side wallwith the septum face to minimize the potential transfer ofmicroorganisms to the inner wall. The opening and the septum face can beconfigured such that the septum face does not engage the inner wall ofthe opening.

One embodiment of the present invention comprises a method for testingthe cannula and septum system described above comprising; configuring atleast one of a septum and a cannula such that the cannula can penetrateat least partially through the septum with reduced contact between theseptum face and the opening, penetrating the septum with the cannula,testing at least one of the cannula and septum for the present ofresidual microorganisms which have passed at least partially through theseptum during the penetration, modifying the configuration of at leastone of a septum and a cannula to reduce the presence of residualmicroorganisms, and repeating at least steps a through c. An embodimentfurther comprises the step of adjusting the compression of the septumprior to the penetrating step. An embodiment further comprises the stepof adjusting the durometer of the septum prior to the penetrating step.An embodiment further comprises the step of adjusting the composition ofthe septum prior to the penetrating step. An embodiment furthercomprises the step of adjusting the elastic modulus of the septum priorto the penetrating step. An embodiment further comprises the step ofadjusting the composition of the septum prior to the penetrating step.An embodiment further comprises the step of adjusting the surfacetexture of the septum prior to the penetrating step. An embodimentfurther comprises the step of adjusting the shape of the face of theseptum prior to the penetrating step. An embodiment further comprisesthe step of adjusting the shape of the opening of the cannula prior tothe penetrating step. An embodiment further comprises the step ofadjusting the angle of contact between the tip of the cannula or theopening prior to the penetrating step.

In another preferred embodiment of the swab pocket device. The swabpocket comprises a system or kit wherein a swab pocket and a swab arepackaged in close association for example within a single common packageand/or within connected sealed packages. Either or both the swab pocketand the swab may be wetted with one or more disinfectant solutions,which can for example be Isopropyl Alcohol (IPA), ChlorhexidineGluconate (ChG), ethanol, and/or an iodaphor, to name a few, or any of anumber of other liquid disinfectant solutions. The swab pocket and theswab could both be wetted with the same liquid disinfectant or theycould be wetted with dissimilar liquid disinfectants. The liquiddisinfectants could be dissimilar in a manner in which the swab haspowerful and substantively instantaneous antimicrobial properties suchas can be imparted by IPA, while the swab pocket has sustained andsubstantively long-term antimicrobial properties such as can be impartedby an IPA/ChG solution or in the alternative the IPA/ChG may be providedon the swab and the IPA only along the swab pocket.

This system or kit is suited for improved disinfection and cleansing ofLuer Access Devices (LAD's) and for helping reduce and minimizebacterial contamination or bacterial load on the access surfaces ofLAD's between uses. The system may be labeled in a manner in which theindication for use is to use the swab first then the swab pocket second.Indices would be provided on the package, preferably alphabetical ornumeric, which distinguish the swabs two component parts, such as forexample “Part 1”, “Step 1 ” and/or “A” for the swab and “Part 2”, “Step2” and/or “B” for the swab pocket. This indication of order ofsequential use provides users with a method for disinfection andprotection according to the present invention.

One method of use is to, as “Step 1”, open and remove the swabdesignated as “Part 1” and/or “A”, from the package. Apply thedisinfectant solution from the swab to the surfaces of the LAD beingcleaned. Access the LAD and administer fluids or medicaments asrequired. Following injection, “Step 2” is performed wherein “Part 2” or“B” is opened and the swab pocket is removed. Apply the disinfectantsolution from the outer surface of the swab pocket to the surfaces ofthe LAD previously accessed then advance the swab pocket over the LAD aspreviously described.

It can be appreciated that the first application of disinfectantsolution from the swab is designed for primary disinfection of theaccess surfaces of the LAD to reduce the bacterial exposure during thesubsequent access and injection of liquid into the LAD. Further, thesubsequent application of disinfectant solution from the outer surfaceand/or at least one other surface of the swab pocket is designed toaugment the primary disinfection and to minimize bacterial load onaccess surfaces of the LAD that may arise from the rebound of thepiston, when the LAD is an open piston type luer access valve. In steptwo, the application of disinfectant solution and covering of the LADvia the swab pocket, post injection, is highly suitable for removing orkilling bacteria which may have been displaced by the piston from thepiston sidewalls, back into the area of the luer tip interface when thepiston rebounds after an injection.

It is the purpose of the present invention to provide a system andmethod, which reminds the healthcare worker to clean the access devicebefore accessing it.

It is the purpose of the present invention to provide a system andmethod, which provides a chemical agent which functions synergisticallywith a solid fluid wave to achieve mechanical elimination of bacteriaduring the insertion, retention, and/or withdrawal of an implement intoand from an access device.

It is the purpose of the present invention to provide a system andmethod for developing medical devices, which achieve optimal mechanicalelimination of bacteria during the insertion of an implement into anaccess device to reduce the dependence on the chemical elimination ofbacteria.

It is the purpose of the present invention to provide a system andmethod which generates a comprehensive solid fluid wave to displaceand/or destroy bacteria from the exposed portion of a medical implementwhich is inserted into an access device.

It is the purpose of the present invention to provide a system andmethod, which provides an outer face which is specifically shaped withinternally projecting elastomeric walls (which can be a tube) to matchthe shape of the leading end of a tubular medical implement duringinsertion, such that a solid fluid wave derived of the elastomeric faceis applied circumferentially to the leading end to eliminate bacteriafrom the leading end.

It is the purpose of the present invention to provide a system andmethod, which is designed to mechanically kill bacteria on medicalaccess devices during the insertion of an implement into the accessdevice using a highly flexible mechanical force, which overcomes boththe flexibility and hiding defenses of bacteria.

It is the purpose of the present invention to provide a system andmethod, which is designed to kill bacteria carried by a medicalimplement by directed, forceful application of an elastomer against theimplement during insertion of the implement into and/or through theaccess device.

It is the purpose of the present invention to provide a system andmethod, which is designed to specifically eliminate bacteria within anaccess device by combined chemical action and mechanical force againstthe bacterial cell wall.

It is the purpose of the present invention to provide a system andmethod, which is designed to provide an inexpensive valve cover whichcan provide this enhanced protection for a cost which does not greatlyexceed the cost of the conventional prepackaged chlorhexidinedisinfectant swab itself.

It is the purpose of the present invention to provide a system andmethod, which is designed to specifically kill bacteria within an accessdevice by combined chemical action and mechanical compression to forcethe chemical agent into compressed juxtaposition with the cell walls ofthe bacteria to increase the exposure of the sacculus to the chemicalagent.

It is the purpose of the present invention to provide a system andmethod, which is designed to specifically kill bacteria within an accessdevice by combining a chemical agent with an elastomer and then bymechanically compressing the elastomer against a medical implement toincrease at least the proximity and/or the release of the chemical agentto target bacteria on the implement.

It is the purpose of the present invention to provide a soft elastomermounted within a rigid or elastic housing wherein the elastomer andhousing are configured such that insertion of an implement against theelastomer causes enclosed compression of the elastomer by the housing toproduce a predictable fluidic dispersion of the elastomer and therebyproducing a solid fluid wave against the implement such that thebacteria residing on the implement and/or the elastomer are destroyed ordisplaced.

It is another purpose of the present invention to provide a softelastomeric sated septum mounted within a rigid or elastic housingwherein the elastomer and housing are configured such that insertion ofa male luer into the slit causes enclosed compression of the elastomerby the housing and against the male luer such that substantially all ofthe bacteria residing on the outside of the male luer are destroyed orwiped off.

It is the purpose of the present invention to provide a luer receivingseptum with an upper face configured such that the outer edge of thecircular end of the luer tip contacts the face first and deflects theface laterally so that the slit opens and the luer is advanced into theslit through the face with minimal or no forceful contact between theinner edge of circular end of the luer tip and the face to minimize thepotential for the displacement of bacteria from the face to the inneredge of the luer.

It is the purpose of the present invention to provide a slitted luerreceiving valve, which provides a tight resting compression force andwhich provides a release mechanism so that the compression force isreleasable by an advancing male luer through the slit and wherein theforce still provides a tight compression force against the wall of theadvancing luer after the release so that the high compression force cantightly seal the resting slit and eliminate bacteria on the wall of theadvancing luer so that the luer can be advanced through an area of tightresting compression with an insertion force which is less than wouldoccur with a similar resting compression without the release mechanism.

It is the purpose of the present invention to provide a slittedelastomeric septum wherein the septum adjacent the slit is highlycompressed by elastic supports (which supports can be elastomeric) whichsupports are at least partially collapsible releasing at least a portionof the compression over a short distance such that the high compressionforce is reestablished against the outer luer wall upon completion ofthe insertion of the luer into the slit.

It is further the purpose of the present invention to provide aluer-receiving valve, which also provides mitigation of negativepressure induced by withdrawal of the luer from the valve.

It is further the purpose of the present invention to provide aluer-receiving valve, which is capable of tight sealing about the luerfor use with high-pressure injection.

It is further the purpose of the present invention to provide aluer-receiving valve or blunt cannula receiving system which a firstslit (which can extend through the proximal face) with a long transverseaxis extending along a first direction and a second slit (which canextend through the distal face) with a long transverse axis extendingalong a second direction, (which second direction can be perpendicularto the first direction) and wherein a first set of opposing slots can beprovided aligned parallel to the first slit and a second set of opposingslots can be provided aligned parallel to the second slit.

BRIEF DESCRIPTION OF THE DRAWINGS

These, as well as other objects and advantages of this invention, willbe more completely understood and appreciated by careful study of thefollowing more detailed description of the presently preferred exemplaryembodiments of the invention taken in conjunction with the accompanyingdrawings, in which:

FIG. 1 is a center section view of a piston luer valve of the prior art.

FIG. 2 is a photograph of a piston luer valve of the prior artdisconnected and connected to the luer at the end of a syringe

FIG. 3 is an electron micrograph from a study performed by the Centerfor Disease Control showing bacteria and biofilm residing within thecircumferential space of the piston luer valve of FIG. 2.

FIG. 4 is a background schematic of a bacterium depicting the outerthree-dimensional elastic stress bearing elastomeric sacculus whichretains the internal fluid.

FIG. 5 is a background schematic of the biologic elastomer,peptidoglycan showing the fundamental Tessera unit which repeats to formthe elastic macromolecule. Note the striking structural similarity ofthe biologic elastomer of the cell wall to a cross-linked molecularstructure of a silicone elastomer, which, according to the presentinvention is used to mechanically destroy or displace the elasticmacromolecule peptidoglycan.

FIG. 6 is a schematic of a mechanical biocide testing system accordingto the present invention.

FIG. 7 is a schematic of a mechanical biocide testing system for a maleluer according to the present invention.

FIG. 8 is a schematic of the lower portion of the elastomeric receiverof figure with a schematic of a variable compressor of the mechanicalbiocide testing system of FIG. 7 according to the present invention.

FIG. 9 is a schematic of an alternative elastomeric receiver of amechanical biocide testing system of FIG. 7 according to the presentinvention.

FIG. 10 is a schematic of an alternative elastomeric receiver of amechanical biocide testing system of FIG. 7 according to the presentinvention.

FIG. 11 is a central section view cut perpendicular to the slit of anembodiment of a luer receiving valve configured to destroy and/ordisplace microorganisms on the penetrating portion of a luer lock orluer slip connector.

FIG. 12 is a perspective view of an embodiment of the septum for usewith the housing of FIG. 11.

FIG. 13 is a perspective view of an alternative embodiment of the septumfor use with the housing of FIG. 11.

FIG. 14 is a side view of an embodiment of the septum of FIG. 12 showingthe resting configuration before installation into the housing.

FIG. 14 a is a side view of an embodiment of the septum of FIG. 12showing the compressed configuration after installation into thehousing.

FIG. 15 is a bottom view of the lower portion of an alternativeembodiment of the septum of FIG. 12.

FIG. 16 is a transverse section view of the lower portion of analternative embodiment of the septum for use with the housing of FIG.11.

FIG. 17 is a transverse section view of the lower portion of analternative embodiment of the septum for use with the housing of FIG.11.

FIG. 18 is a transverse section view of the lower portion of analternative embodiment of the septum for use with the housing of FIG.11.

FIG. 19 is a top view of a dead space free valve similar to the valve ofFIG. 11 especially useful for blood sampling.

FIG. 20 is a section view of the dead space free valve of FIG. 19.

FIG. 21 is a section view of a luer receiving mechanical biocidal cap ordocking station constructed entirely out of elastomer

FIG. 22 is a section view of a luer receiving mechanical biocidal cap ordocking station with an internal elastomer and an outer rigid housing.

FIG. 23 is a section view of a modified male luer.

FIG. 24 is a top view of a disposable anti infective cap insert withinits package.

FIG. 25 is a side view of a disposable anti infective cap insert.

FIG. 26 is a side view of an elastic flip cap for protecting luer valvesor septums.

FIG. 27 is a side view of a blunt cannula configured to minimize outermechanically protected zones for bacteria.

FIG. 27 a is a broken side view of a blunt cannula configured tominimize outer mechanically protected zones for bacteria.

FIG. 28 is a section view of a blunt cannula of FIG. 27.

FIG. 29 is a section view of a blunt cannula of FIG. 27.

FIG. 30 is a side view of a blunt cannula with rapidly varying sidewalldimensions.

FIG. 31 is a longitudinal section view of a mechanical biocidal cannulaand septum system.

FIG. 31 a is a broken longitudinal section view of a mechanical biocidalcannula and septum system.

FIG. 32 is a longitudinal section view of a mechanical biocidal cannula.

FIG. 33 is a longitudinal section view of a mechanical biocidal septum.

FIG. 34 is a top view the mechanical biocidal septum of FIG. 33.

FIG. 35 is a transverse section view through 35-35 of FIG. 33 showingthe proximal slit orientation and the slots aligned with the proximalslit.

FIG. 36 is a transverse section view through 36-36 of FIG. 33 showingthe proximal slit and distal slit orientation and slots aligned with thedistal slit.

FIG. 37 is a transverse section view through 37-37 of FIG. 33 showingthe distal slit orientation.

FIG. 38 is a bottom view of the septum of FIG. 33.

FIG. 39 is a longitudinal section view through a luer receiving valvecovered by a Swab Pocket

FIG. 39 a is a perspective view of a Swab Pocket with a slit forreceiving a branch of a Y-site.

FIG. 39 b is a longitudinal section view through another type of luerreceiving valve covered by a Swab Pocket

FIG. 40 is a perspective view of a Swab Pocket.

FIG. 41 is a top view of one embodiment of the Catheter FlushingExtension Set which employs pinch reservoirs.

FIG. 42 is a top view of one embodiment of the Catheter FlushingExtension Set which employs a catheter flushing slide.

FIG. 41 a is a top view of a catheter flushing slide.

FIG. 43 is a top view of a pharmaceutical mixing packaging system whichincludes a pre filled syringe.

FIG. 44 is a longitudinal section view of a luer receiving valveaccording to the present invention

FIG. 44 a is a longitudinal section view of a luer valve adaptedintroducer according to the present invention.

FIG. 45 a is a perspective view of a luer valve adapted introduceraccording to the present invention.

FIG. 45 b is a perspective view of a luer valve adapted introduceraccording to the present invention in the flexed position.

FIG. 46 is a longitudinal section view of another embodiment of a luerreceiving valve according to the present invention.

FIG. 47 is a front view of a two part Luer Access Device disinfectingsystem.

FIG. 48 is section view of a two part Luer Access Device disinfectingsystem showing a swab and swab pocket device respectively therein.

DESCRIPTION OF THE PRESENTLY PREFERRED EXEMPLARY EMBODIMENTS

FIG. 6 shows a representation of the components of an embodiment of anelastomeric microorganism compression testing system 10 according to thepresent invention. The testing system 10 is designed for investigatingthe mechanical biocidal activity and solid fluid waves induced byvarious elastomers. The testing system 10 is also designed fordeveloping mechanically biocidal devices, which achieve the optimalsolid fluid wave for mechanical elimination of bacteria during theinsertion and storage of an implement into the mechanically biocidaldevice.

The system 10 comprises a contamination source 11 (which can includebacteria or components and/or yeast colonies and/or a solution or anagent which simulates the behavior of the microorganism source), acompressing structure 12, and elastomer member 14 with an outer face 15,a compression receiving medical implement 18, and a biologic detector22. The compressing structure 12 and/or elastomer member 14 can includea portion capable of providing adjustable compression (such as slopedwalls or a frustum shape) or a compression adjuster 26 can be providedwhich delivers focused, and/or circumferential and/or comprehensivecompression. The compressing structure may function to limit thedisplacement of the elastomer without resting compression. One purposeof the compressing structure is to provide for enclosed compression,which favors fluidic dispersion of the solid fluid wave in the oppositedirection of the enclosure. The compression adjuster 26 can for examplebe configured to provide incremental adjustments as for example isprovided by a rotating or otherwise progressively advancing compressingmember 26. This can include comprehensive circumferential incrementalcompression and/or regionally focused compression as for example can beprovided hose clamps of various lengths and cylindrical shapes. Thisexample provides an illustrative example of an action, which can beprovided by the compression adjuster 26.

FIGS. 7 & 8 shows a schematic of an embodiment of the components of anelastomeric microorganism compression testing system 27 with a separatesuspension of bacteria 28, a rigid compressing structure comprised of arigid outer housing schematically shown as 29 (FIG. 8) having an uppersurface 30 angled radially upwardly configured to provide enclosedcompression of an internal elastomeric septum 32 with an upper portion33 having an outer face 34. The housing can have a configuration similarto that of FIG. 11 but with portions removed and replaced withadjustable compressing windows. The outer face 34 includes a centralface portion 36 and a peripheral face portion 37, the septum 32 providesan extension portion 38 and a lower portion 39 and a central slit 40extending from the face 34 through the extension portion 38 and lowerportion 39. Slots 43 below the surface 30 are provided between theseptum 33 and housing 29.

The basic configuration can be for example, similar to the device shownin U.S. Pat. No. 6,171,287, of the present inventor but with the lowerfemale luer connector removed and an opening provided for projection ofan elongated medical implement which as shown is an elongated male luersimulator 48 having an internal lumen 50 and a distal tip 56 with acircular distal end 58. The distal tip 56 defines internal wall portion60 adjacent the end 58 and further defines an external wall 64. Inoperation, the suspension of bacteria 11 are applied to the face 35and/or at least a portion of external wall 56 of the male luer simulator48. A selected portion of the male luer simulator 48 or a portion of theface 35 may be contaminated with the suspension 11. The suspension 11can be allowed to dry if desired and/or an antiseptic may be applied tothe face 34 to simulate conventional practice of wiping the septum. Themale luer simulator 48 is then advanced through the slit at the face 34and through the extension portion 38 and the lower portion 39 to projectbeyond the lower portion 39. A biologic detector (or a biologic testingsystem or method) can then be applied to determine the location, extent,and or number of bacteria contaminating of the tip 64 of the male luersimulator 48 projecting through the lower face 70. Since the bacteriaare killed or wiped off by mechanical force which is in part dependenton the advancing force, the advancing force (and/or speed) ofadvancement the male luer simulator 48 can be controlled and/or variedif desired by using a mechanical advancing device (not shown) tosimulate the ranges of advancing forces which may be applied in clinicalpractice. A video microscope may be used to investigate the behavior ofthe solid fluid wave and its relationship to the male luer simulator 48.In addition a pressure transducer (not shown) can be embedded in thesidewall or at the end of the luer simulator 48 to measure thecompressing force of the elastomer. If desired multiple transducers maybe positioned and a pressure force curve generated for each of thedifferent regions of the male luer simulator over the period ofadvancement and at the end of advancement (and for the withdrawal periodif desired).

Once the initial testing has been completed the housing dimensionsand/or shape and/or the elastomer dimensions and/or shape, and thedurometer, elastic modulus, surface coating, and molecular structure,lubrication, and components of the elastomer can be adjusted to vary thecompression, adhesive forces, and shear forces at various regions of themale luer simulator during advancement to enhance the mechanicalelimination of the microorganisms. After adjustment, the male luersimulator 48 can be re-advanced and the biologic residual afteradvancement retested. For example after an initial trial, the septum 32can be molded with the upper portion 33 thickened by, for example 0.5-2mm or the angle or shape of the face 34 changed, the upper portion ofthe housing 31 may be molded in a more upward ramping configuration, ahydrophilic or antimicrobial coating, and/or a coating or process whichmicroscopically roughens the surface to increase the shear force onbacteria may be added, material such as thin vanes (not shown) may beadded to the slots 43, the extension portion 38 or housing wall adjacentthe extension portion 38 may be thickened (for example by 0.1 mm), thelower portion 32 may be thickened or placed into a configuration offocused compression on the slit 40. Each process can be incremented andrepeated until the optimal configuration is identified.

FIGS. 9 and 10 show simple alternative elastomeric septums for receivingthe simulator 48 and for testing different configurations. The septum 75of FIG. 9 includes an adjustable upper portion 76 and an adjustablelower portion 78. These can be fixed in each progressive position bymolded housings of various dimensions or by a rigid or elasticadjustable support (not shown).

FIGS. 11-18 show various configurations of a luer-receiving valve 80configured to have specific regions for adjustment of compression forcesto allow ready optimization as a mechanical biocide. The valve 80includes an outer housing 81 and an elastomeric septum 82 mounted withthe housing 81. The septum 82 includes an upper portion 88 an extension90 and a lower portion 94 and a central slit 96. The upper portion 88includes an outer face 98 having a facial central portion 99 and afacial peripheral portion 100 (FIG. 12). The face 98 is configured toreceive a male luer 110. The upper portion 88 is sloped upwardly at anangle such that the outer edge 114 of the distal end 120 of the maleluer 110 engages the outer face 98 and deflects the slit 96 open so thatthe inner edge 118 of the distal end 120 of male luer 110 does notforcefully engage the outer face 98 but rather passes into the slit 96as the outer face 98 deflects laterally. When mounted with the housing81, the facial peripheral portion 100 (FIG. 12) of the upper portion 88is deflected upwardly to provided focused compression adjacent the uppersurface of slit 96 and this an adjustable angle which allows readyoptimization of both the compression force at the slit 96, the angle ofengagement of the distal end 120 of the male luer 110 and thecompression and/or shear force of the septum 82 against the luer 110during penetration. In one embodiment the angle is about 30-45 degreesbut other angles may be used. Because the slit begins to open early, theslit begins to shorten early placing compression on the advancing distalend 120 even at the ends 122 and 123 of the slit 96 (FIG. 13). Ifdesired the slit 96 can be shortened to a length less than the outerdiameter of the luer 110 to increase the compression on the externalwall 64 at the ends 122 and 123 of the slit 96. If desired the slit canbe less than 75% of the outer diameter of the luer or can comprise atriangular shaped slit which extends distally as a simple perforationbelow the apex of the triangle.

The lower portion 94 is seated on annular projections, 111 and 112 whichseat within recesses 114 and 116 (FIG. 15). The lower portion 94 issupported by opposing pairs of compression inducers comprising elasticsupport columns 130 & 132 (FIG. 12) directed toward the slit 94 andbowed outwardly to facilitate collapse on compression induced by theluer through the column as will be described. The columns define slots135 and 136 for receiving the displaced lower portion 94 and forreceiving the outwardly collapsed columns 130 & 132 during luerpenetration. As shown in FIG. 14, the lower portion 94 can be moldedwith an upward angle and this can be an adjustable molded angle, whichallows ready optimization of both the compression force at the slit, thecompression and shear force of the septum 82 against the outer wall 138of the luer 110 during penetration without changing the housingconfiguration. In one embodiment the angle of the lower portion 94 asmolded is about 20-45 degrees but other angles may be used. This alsohas the favorable effect of exerting an upward focused compression forceto resting slit 96 at the lower face 139 of the septum 82. Duringdownward deflection of the lower portion 94 during assembly, the columns130 & 132 would be defected internally into a more parallelconfiguration but the outer housing 81 compresses the columns 130 & 132toward the slit such that the columns 130 & 132 again bow outwardly tonear the collapsing position thereby setting the slit 96 in a highlycompressed position which is releasable by advancement of the luer. Theadvancing luer induces the release by collapsing the columns 130 & 132.

One advantage of this configuration is achieved by the longitudinal massof the columns, which will tend to carry lateral movement of the septumdownward. When the advancing luer 110 collapses the columns 130 &132,the elastic laterally directed force of the collapse is carriedlongitudinally along the distal aspect of the slit 96 and this enlargesthe size of the distal opening of the slit 96 beyond distal end 120 ofthe luer 110 to open the slit 96. This column deflection below thedistal end of the luer 110 enhances the elastomeric space below thefully advanced luer 110. In one embodiment the distal end 120 of luer110 fails to reach the end of slit 96 when maximally advanced so thatthe distal opening of the slit 96 beyond distal end 120 of the luer 110is reliably present. (The formation of an elastomeric flow space withinas septum below the fully advanced luer is discussed in U.S. Pat. No.6,171,287 of the present inventor). The space is enlarged when the luer110 is fully advanced and rebounds to reduce in size when the luer 110is retracted thereby mitigating or eliminating any negative pressuredeflection in the channel 150 below the lower face 139 of the septum 82or inducing positive pressure in that channel 150. The flow channel 150below the lower face 139 is configured such that it is easily flushed byfluid from the luer and this is facilitated by positioning the maximumadvancement of the distal end 120 of the male luer 110 above the lowerface 139. If desired a flow deflector (not shown) to induce turbulentflow within the flow channel can be provided. Also, if desired, the slot135 and/or the slot 136 can be connected downward to the open spacewithin the lower luer lock connector (adjacent the male luer projectingwithin the luer lock connector and about the fluid channel 150) withinthe male luer by fenestrations of other connections through the septum82.

FIGS. 19 and 20 show a luer-receiving valve similar to the valve of FIG.11 but with a lower housing 190 modified to provide a dead space freeconfiguration. The septum 200 includes an upper portion 204 mountedabove housing 206 and a lower portion 208 sealed against lower housingportion 190. Ramped flow channel 224 extends from an inlet 230 to aposition below the septum lower portion 208 and through an outlet 233.Flexible medical tubing is shown attached to the inlet 240. This type ofdesign is particularly suitable for blood collection and for bloodtubing, as is used in dialysis or arterial lines. An indicator 250 whichcan be circumferential, visual, or tactile and positioned for example atthe point so that the luer tip is within the extension and the lowerslit is closed when the luer lock housing first exposes the visualindicator. The nurse can be instructed to withdraw blood into a syringewith a luer lock connector (of the type shown in FIG. 11) attached tothe valve, then to rotate the luer lock connector slowly off the valveuntil the indicator is visible below the luer lock connector. At thispoint the nurse lightly retracts the syringe piston to decompress thesyringe and then remove the syringe from the valve. The indicatorindicates a position wherein the septum lower portion occludes the luertip so that the interior of the syringe can be decompressed.

FIG. 21 shows an elastomeric luer-receiving cap or docking station,which is configured to protect the luer during storage. This cap can be,at least partially, comprised of an elastomer of a higher durometer. Theupper portion of the cap is designed to fill the luer lock connector.

FIG. 22 shows a cap configured in a manner similar to the valve of FIG.11 but with a dead end and a connector for connection to tubing or otherstructure.

FIG. 23 shows a pre-filled single use catheter flush syringe forflushing IV catheters. The syringe is conventional except that the maleluer is modified to produce a reduced exposure of the lumen at thedistal tip of the male luer and thereby increase the mechanical biocidaleffect of the luer valve of FIG. 11. The syringe 300 has a largediameter bore (as is used with the Posiflush Syringe, for examplemarketed by Becton Dickinson). The male luer 310 of the syringe includesa very narrow internal lumen 320 (such as a lumen diameter of 1 mm orless) and tapered outer sides 330 of the distal end of the male luer310. The large lumen is not necessary for flush maneuvers and reducesthe contamination exposure area of the lumen at the tip of the maleluer. The smaller lumen also can increase the turbulence immediatelybelow the tip of the syringe, which may have a favorable effect in theflushing of certain valves. However the proximal restriction to flow canreduce the velocity of the jet which projects distally at the end of thecatheter, which may have a favorable effect on delicate endothelium ofthe vein especially for short peripheral catheters in small veins.However this restriction to flow can be reduced by limiting the lengthof the narrowing if desired. According to an embodiment of the presentinvention a medical implement (such as a male luer) is configured tomatch the configuration of the elastomer to optimize the mechanicalanti-infectivity of the combined implement/elastomer system duringoperation. In an example, a filled catheter flush syringe with a luerhaving a large bore diameter and a tip shaped to provide limitedexposure of the lumen and a small distal internal lumen is provided toreduce the potential for contamination of the internal lumen of theluer, to facilitate flushing of the access devices, and to reduce thevelocity of the flow jet against the endothelium wall. Although the antiinfective characteristics of the valves in FIGS. 11 and 20 reduce oreliminate the need for external protection, if desired the protectivecaps of FIG. 21 and/or FIG. 22 can be configured to receive and cap aluer valve itself (such as a those shown in FIG. 11 or 20) compressingthe face of the valve against a protective and mechanically and/orchemically active biocide.

Alternatively a protector for luer valves (such as the valve of FIGS. 11and 20) can comprise an antiseptic containing fabric or gel on one sidebonded or otherwise secure attached on the other side with an elastomeror flexible polymer, which can be moldable during use. The protector canbe configured in a swab pocketor planar configuration and covered by anouter envelope of the type used for example with 70% alcohol swabs.

In one embodiment a rotate able flip cap 400 is provided connected withthe valve by a living plastic hinge or short flexible filament 410 witha circular loop 412 for connection about the valve, the flip cap 400 isdesigned to receive a replaceable anti infective insert 420 (FIGS.24-26), which can be a small fabric swab containing an anti-infectiveagent for mounting within the cap 400 or over the valve. The flip cap400 can be flexible and elastic so as to enlarge in size for insertionover the valve and insert 420 so that the friction fit is secure withoutrotation or a locking mechanism. The flip cap 400 can contain or becomprised of an elastomer, which presses the intervening insert 420against the valve face when the cap 400 is applied. In an embodimentshown in FIG. 24 the insert 420 may be packaged in a watertight tearable container 422 has a circular portion 424 and a handle 430 (whichcan be non-absorbent), which extends away from the swab the handleextends out from under the cap 400 when the cap 400 is applied over theinsert 420 against the valve face. When the nurse desires to access thevalve, the cap 400 with the contained circular portion 424 is rotated,as by rotating projection 425, with pressure thereby rubbing thecircular portion 424 against the valve face and then the cap 400 ispulled off the valve. The valve is then accessed. The handle 430 isgrasped to pull the circular portion out of the cap 400. A new insert420 is then applied with the cap and the cap 400 is flipped closed. Inanother embodiment (not shown) the insert is a swab pocket of fabric orother absorbent material placed over the valve, and then the cap 400 isflipped to snap over the fabric and the underlying valve. The cap 400can be flexible and elastic so as to enlarge in size for insertion overthe valve and insert or fabric swab pocket so that the friction fit issecure without rotation or a locking mechanism although a thread orother locking mechanism may be provided.

In one embodiment (not shown) the cap also includes a projecting memberwhich is sized to be received into the slit. This member can for examplebe impregnated with an anti infective agent or can contain an antiinfective agent which is released when the member is compressed by theslit wall of the valve.

It should be understood that many valve configurations are includedwithin this teaching. The face could comprise a funnel shape or apartial funnel shape. The upper portion can vary in thickness from thecentral to the peripheral position. The thickness of the columns couldvary between the more proximal column portions and the distal columnportions. The elastomer could be iodinated or contain pockets containingan anti-infective agent or an agent, which alters the elastic modulus ofthe sacculus. The biocidal and bio-displacement action of theelastomeric solid fluid wave can be applied to other medical devices.For example, smooth planar areas, which need frequent clearing ofbacteria such as a food preparation surface, can be engaged byelastomeric compression as, for example, by an elongated solid fluidwave. The force of the pressured application of the elastomer against asurface, the frequency of application and the scope of the advance ofthe solid fluid wave can be automated. To enhance the sliding action ofthe solid fluid wave the elastomer can be highly compressed over only avery thin region such as 1-4 mm. This approach may be particularlyuseful for use to produce mechanically biocidal syringe barrel andpiston configurations where resistance to advancement is a veryimportant feature.

In another embodiment as shown in FIG. 27-29, a mechanically biocidalblunt cannula 500 is provided which is specifically configured tooptimize comprehensive mechanical force against the outer wall 510 ofthe cannula and to reduce the potential for bacteria adjacent the distalopening to escape the wiping or compressive mechanical force of theseptum during insertion and withdrawal into and from an elastomericseptum. The cannula 500 has a solid distal tip 520 which can be sharp orblunt and at least one distal opening 530 adjacent the tip which extendsto a lumen 540 within the cannula. The cannula has a proximal end 550for connection with a luer. The distal opening 530 slopes interiorly sothat bacteria carried along by the solid fluid wave are not deposited onan edge adjacent the opening but rather carried past the opening orotherwise destroyed during the insertion process. FIG. 27 a shows analternative biocidal cannula 555 configuration with a solid distal tip560 and outer wall 570 a distal opening 580 and a lumen 590.

FIG. 30 shows an alternative embodiment of a mechanically biocidalcannula 600 with a variable outer dimension for insertion into a septum610. The cannula has a distal portion 620 with a lesser diameteradjacent the opening 630 and a larger diameter portion 640 adjacent theopening 630. The larger upper dimension holds the slit apart to agreater extent than the diameter of the distal portion 620 to allowfluid to flow from the opening 630 and into the flow path 640 below theseptum 610 when the L2 is of greater length than L1. This eliminatesnegative pressure within the flow path 640 associated with withdrawal ofthe biocidal cannula 600. If preferred the septum 610 can be as long,longer, or nearly as long as the cannula 600 and is preferably undercompression (which may be variable) thereby increasing the compressivecontact with the cannula 600.

In an embodiment a method of monitoring an IV system for contaminationis provided, the method comprises steps of advancing a male luer into avalve and investigating the male luer outer portion, such as the tip,for evidence of contamination subsequent to the advancing step. In oneembodiment the male luer functions as a probe (or a swab), which entersthe valve in question and collects a specimen (as on its outer surface)from the interior of the valve for assessment. The evaluation of themale luer (such as the outer surface of the male luer) may be a routinepart of IV access. The biologic detector may be mounted on the IV poleand used to access the luer before and/or after each connection or canbe employed for spot surveillance purposes. In an alternativeembodiment, used for surveillance, a specialized swab or collectiondevice fashioned in the shape of a male luer may be provided.

FIG. 31 shows a combination mechanically biocidal cannula and septumsystem 700 wherein the septum 704 has a central slit or perforation 708and the septum 704 is under high compression. The septum 704 can becylindrical and wedged into a frustum shaped receiver to provide greatercompression from its proximal to distal extent to allow easy penetrationwith but high distal compression force. The upper portion 710 can bedisplaced proximally to increase the compression at the upper surface714. In one embodiment the septum 704 is of a durometer of about 10-30or less so that the elastomer flows under high compression will entermicroscopic crevices wherein bacteria may otherwise be protected fromcompression or shear forces. The cannula 718 can have a centering member720 such as a longitudinal guide, which engages a distal end, 724 of theseptum housing 728. If preferred a very short slit (or only apreperforation induced by a needle) and/or compression force can be highduring the insertion which can result in penetration forces which arehigh. According to one aspect of the invention an advancing(penetration) force amplifier (such as projecting threads 730) isprovided and engaged prior to the contact of the tip 732 of the cannula718 to the compressed septum so that the nurse does not perceive thepenetration forces as high and rather has a ready mechanism to overcomethe penetration force by simply aligning the centering member 720 of thecannula 718 and the septum housing 728 and then threading the centeringmember 720 onto the housing 728.

As shown in FIG. 31 (and also in FIG. 31 a) the slit or perforation 708(FIG. 31) can be offset from the center to reduce the potential for thedevelopment of a reduced zone of compression at the distal tip 732 ofthe cannula 718. A larger receptacle or slot 740 may be present on theside of the septum 704 with the greater septum mass so the slit orperforation 708 shifts toward the midline with septum displacementduring insertion in cooperation with the effect of the centering member720 of the cannula 732. The upper surface 750 of the housing 728 and theupper surface 714 septum 704 can be matched with the outer surface ofthe cannula 760 and inner surface 780 of the centering member 720 toprovide a compression region during forced juxtaposition of thesesurfaces with insertion.

FIG. 31 a shows an alternative configuration of a septum 800 for usewith a mechanically biocidal cannula and septum system of the typesimilar to that shown in FIG. 31. The upper surface 808 of the septum800 is matched with the tip 810 of the cannula 814 such the uppersurface has a depression 820 with a diameter matched to the diameter ofthe end of tip 810. The larger slot 830 is larger in its proximal extentto accommodate the central shift discussed above. As shown, the diametercan be but slightly larger prevent fluid from being trapped between thetip 810 and the depression 820 during insertion. The depression 820 canserve as a reservoir for receipt of a projection of a disinfection capof the type similar to that shown in FIG. 26.

In one embodiment shown in FIG. 32-38 the septum 900 has a proximal slit904 which extends to a position adjacent the distal end 908 (FIG. 38) ofthe septum 900 (although, if preferred the slit can extend all of theway through the septum 900). The septum 900 has a distal slit 910perpendicular (or otherwise angled) with respect to the proximal slit904. The biocidal cannula 914 (FIG. 32) can be of the type similar tothat shown in FIG. 27-29 with opposing distal openings 915 (positionedat the end of flow channel 916) which are aligned, as by matching acannula guide 917 and a conventional lockable guide on the septumhousing (not shown) so that with insertion of the cannula 914 into theslit will cause the openings to be aligned with and communicate with aperpendicular slit 910. The cannula 914 length and the septum 908 lengthcan be matched so that the openings in the cannula 914 line up withopened perpendicular slit 910 when the cannula 914 is maximally advancedwith the cannula tip 918 projecting to a point just proximal to thedistal end 908 of the septum 904. The cannula 914 can include aconventional locking mechanism such as clips 919 to retain the cannula914 in an advanced position with the openings 915 aligned with theopened perpendicular slit 910.

When the cannula 914 is fully advanced and locked in position within theseptum, the perpendicular slit 910 is separated into two opposing slits920 and 924, which become divided and separated by the now interposingcannula 914 within slit 904. With the cannula 914 fully advanced andlocked in place, the opposing slits 920 and 924 are distorted by thedistal end 918 of the cannula 914 into an open position so that theopposing slits 920 and 924 communicate with the opposing openings 915and the flow channel (not shown) adjacent the distal end 908 of theseptum 900. To facilitate the opening of the proximal slit 904, theseptum 900 has a first set of slots 930 for receiving displaced septummass parallel with the proximal slit 904. In addition, to facilitate theopening of the distal perpendicular slits 920 and 924 (along a differenttransverse axis than the displacement of the more proximal displacedseptum mass) a second, more distal set of slots 940 is provided parallelwith the perpendicular slits 920 and 924.

In an alternative embodiment (not shown) similar to the aboveembodiment, the proximal slit 904 can be lengthened to the to extendthrough the septum end 908 and the opposing distal openings 915 of thecannula 914 can alternatively be aligned (as by matching guides on thecannula and housing) so that, with insertion, the openings 915 arealigned with, and communicate with the distal end of the slit 904, thelong transverse axis of slit 904 can be extended to adjacent the end 908of the septum 900 to accommodate the flow of liquid out the openings915. In this embodiment, the transverse length of the distal ends of theslit 904 adjacent the distal septum end 908 is longer than the diameterof the cannula 914 so that opposing spaces are opened adjacent thecannula 914 adjacent the end of the slit 904.

FIGS. 39, 39 a, and 39 b show embodiments of a “Swab Pocket™” 950 forreducing MTEs by covering the valves, such as those discussed above. Theswab pocket serves as both a valve facial swab and a valve cover. Unlikeconventional swabs, the swab pocket is preferably applied after thecannula or luer has been removed from the valve. In one embodiment, theswab pocket 950 includes an absorbent inner layer 952 preferablycomprised of elastic fabric or otherwise the swab pocket may benon-elastic and comprised, for example, of a thin layer of absorbentcotton with an outer layer 954, which can for example be comprised ofpolyethylene terephthalate. (This material is in wide medical use and issold for example in combination with cotton under the trade name Telfa).Alternatively, other suitable medical grade material which is atpartially impermeable to reduce evaporation of disinfectant liquid (ifan evaporable liquid is used) from the swab pocket 950 may be used andthe proximal end of the outer layer 954 may curl in to cover theproximal end of the inner layer 952 to further minimize evaporation.

In one embodiment the swab pocket 950, has an open-able end 960 and theswab pocket 950 is packaged in a clear package such as that shown inFIG. 24 with the open-able end 960 in a closed configuration. Duringoperation the sides 970 and 972 of the swab pocket 950 are squeezed (asindicated by the arrows) to open the open end 960 of the swab pocket 950for insertion over a valve. The absorbent inner layer 952 preferablycontains a chemical disinfectant such as, for example chlorhexidine withor without alcohol, or an iodaphor. A separate or attached absorbentinsert or other reservoir of disinfectant (discussed below) can beprovided within the swab pocket 950 if desired. It is preferable for thedisinfectant to have a low volatility or can be mixed with or covered bya substance of low volatility such medical grade silicone oil (of thetype used for example to lubricate syringes) to enhance retention.Medical grade silicone oil has the added value of providing a lubricantto reduce penetration force despite compression. This simple swab pocket950 provides a very inexpensive self securing cover which functions toprotect a valve from contact contamination or droplet nuclei and alsofunctions to provide a ready source of disinfectant at the face 980(FIG. 39 b) of a valve 955. One of the purposes of this invention is toprovide a very simple cover which is so inexpensive that it can beimplemented in countries or hospitals which lack the resources toaccommodate the considerable additional expense associated with the usesof more robust caps for all access sites. This embodiment can providethis enhanced protection, and serve as a continuous reminder to swabbecause it is already in place and must be removed to access the device.According to the present invention, these functionalities can beachieved, for a cost which does not greatly exceed the cost of theconventional prepackaged chlorhexidine disinfectant swab itself.

In an embodiment a swab pocket 978 has at least one elastic componentwhich can, for example be an integral, insert molded, bonded orotherwise attached, elastic band 974 (FIG. 39 a) located adjacent theopen end of the swab pocket 978. Alternatively, the entire swab pocket978 may be elastic or the swab pocket outer layer 954 may be elastic.The swab pocket 978 can include or be comprised of another componentwith shape memory, such as, for example, an outer layer 954 comprised ofelastomeric material integral, bonded or otherwise attached to an innerlayer or component which contains disinfectant. The outer layer can forexample be an optically clear elastic silicone sleeve, coating or moldedcomponent. The outer layer can for example be molded with the fabric ormolded into the fabric. Alternatively the entire swab pocket may becomprised of an optically clear elastic silicone and/or of material withelastic shape memory such as the moldable elastomere sold under thetrade name Zello™ marketed by Zeller International with an internalpocket containing releasable disinfectant.

As shown in FIG. 39 b an internal pocket 948 can for example include aninsert molded sponge or fabric 950 at the blind end 952 of the swabpocket 954. In an example, the swab pocket 954 may be may be moldedwoven for formed with the insert 950 in the internal pocket 948 (such ascotton) adjacent the inner surface of the blind end 952 of swab pocket954 for containing the disinfectant The insert 950 may be covered with athin layer 958 of water resistant material such as silicone havingperforations or through serrations 960 so that disinfectant is releasedthrough the perforations or serrations 960 upon digital pressure appliedagainst the top 953 of the swab pocket 954. Alternatively, the outerlayer 961 of the swab pocket can be comprised of optically clearelastomere. The outer layer 961 can be integral or otherwise engaged (asfor example bonded) to at least a portion of the swab pocket 954, sothat the swab pocket 954 can be secured to the valve 962 by the shapememory and/or elastic rebound of the swab pocket 954 without the needfor the covering flip cap 400 (FIG. 26) or other cover or cap.

Alternatively the swab pocket 954 can be packaged in a more “open pocketshape” with a distal opening being slightly closed or slightly open. Theswab pocket 954 can comprise a narrow neck with or without an enlargingdistal end to provide a shape memory to providing tight engagement withthe valve while allowing easy insertion over the valve. The neck oropening can be squeezed at the time of application over the valve toopen it or enlarge the opening. The tight elastomeric neck with anenlarged distal end allows for a generally universal secure attachmentto different shaped valves. The tight neck may also be employed toreduce the potential the loss of a volatile disinfectant (if employed).

In an alternative embodiment the swab pocket is comprised entirely ofnon elastic material. In an example the inner layer can comprise a thinlayer of absorbent cotton impregnated with a chlorhexidine alcoholmixture or and the outer layer, can be comprised of polyethyleneterephthalate. The swab pocket may be specifically formed to fit over aspecific valve shape. A tether, latch or other connecting member may beprovided for securing the swab pocket to the valve.

In another embodiment a slit 970 (FIG. 39 a) may be provided adjacentthe open able end 972. The slit 970 may have at least one elasticportion 974 for receiving the branch of a y-site (not shown) and forelastically holding the swab pocket 978 over the branch of a y site tosecure the valve to and over the y site.

In another embodiment (not shown) a facial covering is provided (whichcan be a swab pocket for attachment by the user or can be applied duringmanufacture). The facial covering is left in place for 72 hours or ispermanently attached. The covering has a slit or perforation forreceiving the luer tip or blunt cannula with the walls defining the slitin the swab pocket sealed or otherwise bonded so that portions of fabriccannot be displaced by the advancing luer or cannula. In one embodimentthe fabric is about 2-3 mm adjacent the central slit so that thepressure of the luer against the swab pocket immediately before andduring insertion increases the release of disinfectant from the fabric.The disinfectant from other portions of the fabric then diffuses intothe portion adjacent the slit. If preferred, fabric or sponge containingdisinfectant can be onset molded or otherwise provided into or with theseptum so that disinfectant is released on pressure during luerinsertion.

FIG. 41 shows an catheter flushing extension set 1000 similar to thatdisclosed in U.S. patent application Ser. No. 10/533,749 of the presentinventor, the contents of which are incorporated by reference as ifcompletely disclosed herein, for use with an indwelling catheter 1010and which is designed to both reduce the number of accesses as well asthe MTE % and MTE Magnitude. The catheter flushing extension set 1000 isshown with a short length of tubing 1011 (which can be comprised forexample of silicone) with a plurality of flexible pinch reservoirs 1012,1014, 1016 which can be reversibly moved from the open to closedposition. The reservoirs have a stable closed position so that once theyare pinched they remain closed until re-inflated. Each time one of thereservoirs 1012, 1014 or 1016 is closed the fluid from that reservoirsquirts out the catheter tip 1020 and flushes it. The catheter flushingextension set 1000 can have 9 reservoirs or more if desired so that allflushing over a 72 hour period can be accomplished by closing reservoirsrather than by attaching an external saline flush syringe. Thereservoirs 1012, 1014, 1016 are readily reopened by occluding the tubingby digital pressure adjacent the catheter hub 1030 and then injectingsaline into the system essentially popping open the reservoirs 1012,1014, 1016. The proximal terminal 1032 is preferably closed by anattached biocidal septum 1034 so that, in addition to reducing thenumber of accesses (and therefore the number of MTEs) the catheterflushing extension set 1000 can also reduce the MTE % and MTE Magnitude.The implementation of the catheter flushing set 1000 hospital wide canalso result in considerable savings by eliminating the need for a largepercentage of the pre-filled saline flush syringes (which are expensiveto employ in high numbers).

FIG. 42 shows another embodiment according to the present invention ofcatheter flushing extension set system 2000 similar to that disclosed inUS patent application for use with an indwelling catheter 2010 and whichis designed to both reduce the number of accesses as well as the MTE %and MTE Magnitude. The extension set 2000 is shown with a catheterflushing slide 2015 which can be reversibly moved along the tubing 2018.The catheter flushing slide 2015 has a tubing receiving slot 2020 withthree regions (positions) for receiving the tubing 2018; an openposition 2021, a slide position 2022, and a locked position 2023. Eachof the regions on the slide 2015 around each position may be color codedor otherwise well marked with the region around the open 2021 being, forexample green, the region around the slide position 2022 being yellow,and the region around the locked position 2023 being red. The slide 2015is preferably comprised of plastic with very slick opposing surfaces2040 and 2041 of the open position for sliding engaging the tubing 2018to produce peristaltic forward movement of the fluid in the segment. Theslide 2015 may for example have a lubricating coating on at least theopposing surfaces 2040 and 2041 slide portion. The tubing 2018 has marks2050 along the tubing 2018 to designate each new, more advanced slidingflush position. The tubing 2018 preferably has a low rebound force sothat a substantial vacuum does not develop in the tubing 2018 after theslide 2015 has been slid along the tubing 2018 and a significant portionof the tubing is in a closed position state. Each time the slide 2015 isadvanced the fluid from the segment of tubing 2018 compressed by theslide 2015 squirts fluid out the catheter tip 2060 and flushes it. Thecatheter flushing extension set 2000 can have 9 slide positions (marks)for the slide 2015 or more if desired so that all flushing over a 72hour period can be accomplished by advancing the slide 2015 rather thanby attaching an external saline flush syringe. The catheter flushingextension set 2000 can be refilled with saline by attaching a pre-filledsyringe to the access port 2070 and injecting saline, this expands thetubing 2018 proximal the slide 2015. The nurse then moves the slide 2015to the open position 2021 and continues to inject saline so that thetubing is full of saline (or other flush solution) and so that no refluxof blood into catheter tip 2060 occurs during the tubing 2018 refillingprocess. If a piggy back infusion is due and no prior flush is plannedthen the piggy back is connected to the portal 2070 and opened to openthe tubing 2018 proximal the slide 2015 then the slide is moved to theopen position 2021. According to the invention, other means for causingflushing from a plurality of extension set segments such as, for examplea moving peristaltic roller, with for example two opposing rollers heldby a small graspable housing and movable along the tubing (andcompressing the tubing between the rollers with each advancement) canalso be employed in a similar fashion to that described for the slidediscussed above.

FIG. 42 a shows an integrated self flushing catheter with side mountedtubing and a slide of the type shown in FIG. 42.

FIG. 43 shows a syringe packaging system 3000 which comprises anotherembodiment intended to reduce MTEs by reducing contact contamination ofthe biocidal cannula and also intended to provide enclosed mixing of adiluent and pharmaceutical which reduces nursing exposure to thepharmaceutical and further reduces the potential for contamination ofthe mixture during the mixing process. The syringe packaging system 3000can be of the type described and claimed in U.S. Pat. No. 5,769,825entitled. “Self-contained syringe and pharmaceutical packaging systemfor enclosed mixing of pharmaceutical and diluent” of the presentinventor, the contents of which are incorporated by reference as ifcompletely disclosed herein, As shown in FIG. 43 an outer package 3010comprises two opposing and bonded layers, an upper clear layer 3014 anda lower layer 3018 which may be opaque or clear. The layers areseparated in region to defining a lower chamber 3020 which contains acapped pharmaceutical vial 3024 containing a pharmaceutical agent and anupper chamber 3028 which contains a pre filled syringe 3030 having aselected pre-filled volume which is matched to provide the properdilution of the agent in the vial 3024. The syringe 3030 has a biocidalcannula 3040 attached with a tip projecting into a pathway 3044 (whichcan define a cylindrical portion). The drug vial septum 3048 is coveredwith a thin plastic cap 3050. The septum 3048 is configured such thatthe tip 3055 can penetrate the septum 3048 of the drug vial 3024. In analternative configuration (not shown) the septum 3048 can incorporatethe tip of the cannula or the tip of the luer end of the syringe bymolding the tip of cannula or luer end of the syringe in a positionpartially through the septum or by pre inserting tip of cannula or luerend of the syringe partially through the septum and fixing it in thatposition during or before packaging. This allows ready penetration intothe drug vial. The pre-filled diluent syringe 3030 can be similar inconfiguration to the type marketed by the Becton Dickinson under thetrade name Posiflush. The short, squat configuration of the Posiflushsyringe, and the short extension length of the syringe with thewithdrawn piston, facilitates efficient and compact packaging with thedrug vial and operation within the enclosed package.

In operation the little plastic cover cap 3050 over the septum 3048 ofthe drug vial 3024 is removed by grasping it through the package 3010and allowed to fall inside the lower chamber 3020 adjacent the vial3024. If a cannula cap (not shown) is present over the cannula 3040 thisis also removed by grasping it through the package 3010. The drug vial3024 and syringe 3030 are then advanced together to cause the cannula3040 to enter the inner chamber of the vial 3024. A small amount of airis withdrawn into the syringe 3030 from the vial 3024, if desired, tominimize pressure build up in the vial 3024. With the vial 3024 heldwith any aspirated air near the plunger 3060, the diluent is theninjected into the vial 3024. The vial 3024 and the attached syringe 3020are shaken as a single unit. The entire package 3010 is held so that thevial 3024 is on the top and the mixture is aspirated into the syringe3010. The entire package 3010 is then taken directly to the bedside (ifthe entire procedure was not performed at the bedside) and then openedat the pre tear site 3070 and the syringe 3030 is removed and connecteddirectly to the biocidal cannula 3040 for injection.

The combination of enclosed drug and diluent mixing with the use of abiocidal septum and cannula provides for protection againstcontamination during each sequential process of drug delivery which isparticularly useful with medication provided in the home or in avulnerable population such as bone marrow transplant recipients orpatients receiving chemotherapy. The enclosed mixing also has theadvantage of greatly reducing exposure of the nurses to aerosols orother means of occupational chemotherapy exposure. The biocidal cannulaand biocidal septum have many additional uses and can be provided insubstantially any environment or system wherein fluid access into apatient's body is desired.

In an alternative embodiment the pre-filled syringe and drug vial can beshrink wrapped together in alignment with a small flexible cylindricalchannel between for advancing the cannula when engagement is desired.The shrink wrapping can help prevent inadvertent advancement. Forstorage the package and its connecting cylindrical portion can be flexedso that the syringe and vial are stored and secured to each other sideby side for ease of standing in typical hospital drug storagecontainers. When mixing an injection is desired, the package is carriedto the bedside, the wrapped syringe and vial are straightened from theirside by side flexed position into alignment, and the procedure describedabove performed.

FIG. 44 shows a closed bloodless catheterization system intended toreduce MTEs during catheterization and to reduce the risk of airembolism and reduce hospital worker blood exposure duringcatheterization. In one embodiment, the luer receiving valve 4000 forreceiving a male luer 110 of a luer lock connector (shown in FIG. 11) ispermanently attached to a peripheral catheter (for example of the typeshown in FIG. 42), a central venous catheter, femoral catheters, picc,midline catheter or other catheter so that inadvertent disconnection(with attendant deadly silent air embolism and bleeding) is reliablyprevented. The valve 4000 can be provided at the proximal terminal of acardiac or other diagnostic or interventional catheter introducer forfemoral, brachial, jugular, subclavian, or radial catheter, for examplefor stent, guide wire, or diagnostic catheter introduction (to name afew). The luer receiving valve 4000 is similar in configuration to thatshown for example in FIG. 2 of U.S. Pat. No. 6,908,459 and in variousfigures of U.S. Pat. No. 6,171,287, the contents of which areincorporated by reference as if completely disclosed herein. However,the lower portion 4004 of the septum 4006 is modified to form an outerelastomeric tube 4008 for intussusception over an inner tube 4010 aboutthe flow channel 4012. The length of the downwardly projecting septum1014 is greater than the length of the male luer 110 (FIG. 11) so thatnegative pressure is mitigated or eliminated upon withdrawal of the luerfrom the septum. The outer wall 4018 of the inner tube 4010 can beupwardly tapering to facilitate insertion of the outer tube 4008 overthe inner tube 4010. If desired support columns (not shown) may beprovided between the proximal portion 4020 and the distal septum portion4024 of the lower septum portion 4004. The outer tube 4008 may besecurely held about the inner tube 4010 by tight wedging, by adhesive,or by an overhanging ledge or projection (not shown) above the distalportion 4024.

In FIG. 44 a, a luer receiving valve adapted introducer 4030 is providedfor receiving the guide wire, diagnostic catheter or devices, orinterventional catheter or devices collectively illustrated as elongatedimplement 4032. The valve adapted introducer 4030 has a distalprojecting member 4036 (which can be configured to have the outerdimensions of an ANSI standard male luer) and a handle 4038 and a lumen4039 extending through the projecting member 4036. Although not shown inthis figure, if desired, the valve adapted introducer 4030 can have adownwardly projecting luer lock portion (of the shown in FIG. 11) forthreading in and out of fluid connection with the flow channel 4012. Thewithdrawal or threading out maneuver will allow the distal septumportion 4024 to rebound about the elongated implement 4032 to stabilizethe elongated implement 4032 in a fixed position. The handle 4038 of thevalve adapted introducer 4030 provides an upper funnel opening 4039 forreceiving the elongated implement 4032. As shown in FIGS. 45 a and 45 b,the opening has a thin wall 4040 with opposing slits 4041 so thatopposing semicircular sides 4042 and 4044 can be flexed towards eachother by compression (as by the thumb and finger along the axis shown byarrows in FIG. 45 b) and then moved back to the non-flexed position byrebound or by applying pressure perpendicular to the flexing pressure.If preferred the valve adapted introducer 4030 can be modified so thatboth the flexed and non-flexed positions are stable so that theelongated implement 4032 can be either readily movable or fixeddepending on whether the handle is in the non-flexed or flexed position.In FIG. 44 a, the handle 4038 is covered with an optional elastomericboot 4045.

The valve adapted introducer 4030 are preferably configured to engagethe valve 4000 such that a guide wire being withdrawn through anattached catheter (as during insertion or exchange of the catheter bythe “over the guide wire” technique) will be funneled into the valve4000 and/or the luer valve adapted introducer 4030 rather than becomingcaught along the flow channel 4012.

The luer valve adapted introducer allows performance of a method ofclosed catheterization. An example follows: When a catheter (for examplea multi-lumen catheter) having attached valve(s) at the terminal(s) isbeing inserted by this closed catheterization method, a luer end of asyringe containing saline (with or without an anticoagulant) is firstinserted into each the luer valve and each lumen is flushed. The needleis then inserted into a blood vessel and a guide wire advanced into thevessel. The luer valve adapted introducer is inserted into the valve andthe catheter fed over the guide wire in the usual way. The luer valveadapted introducer assists in guiding the wire through the valve and outthe luer valve adapted introducer where it is grabbed and the catheteris then advanced to the desired position in the vein over the wire. Thewire is then removed and a syringe with a male luer is advanced into thevalve, the lumen is checked for residual air by aspiration and then thedistal lumen is flushed. The entire process is carried out withoutatmospheric exposure of the interior of the valve, the lumen, or theblood vessel.

In another example, a conventional outer cardiac catheter introducingcatheter (also called an “introducer”) is provided in the sterilepackage with a fixed luer valve in place which may be integral with theouter introducing catheter. The outer introducing catheter is inserted(for example into the femoral vein) using the closed catheterizationmethod described above. A luer valve adapted introducer with a lumensized for diagnostic and/or interventional cardiac catheters ispositioned over the end of the cardiac catheter (or may be provided withand previously mounted over the cardiac catheter). The luer valveadapted introducer and the catheter can be inserted together or the luervalve adapted introducer can be inserted first and then the cardiaccatheter inserted through it. The procedure is then carried out, whencatheter fixation is desired this can be achieved by flexing the handleof the luer valve adapted introducer or by withdrawing the luer valveadapted introducer partially from the luer valve (as discussed above).On catheter exchange there is no bleed back or risk of air embolismsince the lumen of the indwelling outer cardiac catheter introducer isnever opened. When the procedure is completed, or if desired during theprocedure, the cardiac catheter can be removed and blood at very highflow rate or rapid high volume fluid resuscitation can be immediatelyadministered without opening the system though a luer inserted into thevalve. The procedure can then be restarted again without opening thesystem. If a side port is provided on the outer cardiac catheterintroducer with a fixed luer valve fluid can be administered at the sametime the procedure is being performed. Again all of this can beperformed without opening the system in the conventional manner. Thissame technique can be applied to vascular catheterization forangiography or vascular stent placement. For some elongated implementssuch as a diagnostic cardiac catheter the desired internal lumen of theluer adapted introducer may be much smaller than that of a conventionalluer. For large interventional devices it may be desirable to have aninternal lumen within the luer valve adapted introducer larger than thatof a conventional luer. A finely adjustable lumen diameter, as can forexample be provided by a compressible touy boyst fitting (touy boystfitting are well known in the art), mounted in the handle of the luervalve adapted introducer can be provided if a single luer valve adaptedintroducer is desired for a wide range of catheters.

FIG. 46 shows a modified valve 4050 with a second elastomeric tube 4055projecting within a rigid inner tube 4060. The second elastomeric tube4055 serves to guide the guide wire through the valve 4050, to furtherstabilize the distal septum portion 4065 against downward deflection,and to minimize deadspace.

As noted, the ability to easily introduce a guidewire or other elongatedmedical implement through a permanently or near permanently fixed valvesealing the proximal end of a catheter or introducer greatly reduces therisk of air embolism and hemorrhage due to inadvertent disconnect. Inaddition, all of this is accomplished while maintaining a closed systemthroughout the procedure of catheter insertion, catheter exchange,cardiac catheterization, or any of a wide range of diagnostic andinterventional procedures involving the vasculature or other internalbody accesses (such as ureteral catheterization). Another advantage ofthis approach is that the luer valve access terminal, through which thecardiac catheterization for example is being carried out, is immediatelyavailable at any time during or after the procedure for the closedadministration of very high flow blood and other fluids through the luervalve without the need for disconnection or opening the system orinsertion of another large bore catheter. A final advantage is that thevalve never does need to be removed for insertion, guide wire exchange,repositioning, or for insertion of diagnostic or therapeutic implementsso that the catheter terminal is never opened and exposed to theatmosphere in the conventional manner associated with removal of thevalve or with insertion without the valve in place. In an example of thedegree with which this maintains a closed system a multi-lumen cathetercan be provided in the sealed package with valves secured and closingall terminals, and the catheter can be inserted using the over-the-wiretechnique without removing a single valve by inserting the wire throughthe valve in fluid connection with the distal lumen.

FIG. 47 shows a two part Luer Access Device disinfecting system 5010.The system comprises a pair of conjoined packages 5011 and 5012. Thepackages are selectively detachable from each other via perforation5013. Further, each package has notches 145014 and 5015 designed toindicate to users where to open the package. Notches 5014 and 5015 alsoserve to selectively weaken the package in such a manner that users cantear the package open manually. Indices, 5016 and 5017 are provided inorder to designate a visual difference between the two packages andtheir contents.

FIG. 48 is a cutaway view into system 5010 wherein swab 5018 and swabpocket 5019 can be seen isolated each from the other. In accordance withstandard alcohol wipe type products the packages 5011 and 5012 also holda measure of liquid disinfectant 5012 which liquid disinfectant alsosaturates the devices therein.

The method of use is to open and remove swab 5018, designated as “Part1”, from package 5011. Apply the disinfectant solution from swab 5018 tothe surfaces of a LAD. Then access the LAD and administer fluids ormedicaments as required. Following injection, package 5012, labeled as“Part 2”, is opened and swab pocket 5019 is removed. The outer surfaceof the swab is rubbed against the surface of the LAD to apply bothfrictional cleansing and disinfectant solution from swab pocket 5019 tothe surfaces of the LAD previously accessed. The swab pocket 5019 isthen advanced over the LAD to cover the LAD so that swab pocket 5019remains in place to protect the LAD from contamination between accesses.

Although the presently preferred embodiments have been described, itwill be obvious to those skilled in the art that various changes andmodifications can be made without departing from the invention. Whilethe invention has been described in connection with what is presentlyconsidered to be the most practical and preferred embodiments, it is tobe understood that the invention is not to be limited to the disclosedembodiments.

1. A system for enhancing safety of a patient having an indwellingintravenous catheter comprising: a. a luer valve having a swabbable facefor receiving a male luer, the luer valve further having a proximal endwith an externally threaded portion defining a first diameter forreceiving a matching internally threaded shroud of a luer lock connectoradjacent the swabbable face, the luer valve further defining a bodyportion proximal the externally threaded portion, the body portionhaving an outer wall defining a second diameter greater than the firstdiameter, and b. a sterile cover sized to be mounted over the swabbableface and the entire externally threaded portion, and at least a portionof the body portion, the sterile cover defining an opening, the openingbeing sized so that the opening is forcibly dilated by the body portionwhen the sterile cover is mounted over the body portion, to therebycontact said outer wall of the body portion.
 2. A system for enhancingsafety of a patient having an indwelling intravenous cathetercomprising: a. a luer valve having a swabbable face for receiving a maleluer, the luer valve further having an proximal end with an externallythreaded portion defining a first diameter for receiving a matchinginternally threaded shroud of a luer lock connector adjacent theswabbable face, the luer valve further defining a body portion proximalthe externally threaded portion, the body portion having an outer walldefining a second diameter greater than the first diameter, and b. asterile cover sized to be mounted over the swabbable face and the entireexternally threaded portion, and at least a portion of the body portion,the sterile cover defining an elastic opening, the elastic opening beingsized so that the elastic opening is elastically dilated when thesterile cover is mounted over the body portion, the elastic openingrebounding to elastically grip the outer wall of the body portion sothat the sterile cover is snuggly retained over the swabbable face, theexternally threaded portion, and at least a portion of the body portion.3. The system according to claim 2 wherein the cover is flattened in itsstored configuration.
 4. A system for enhancing safety of a patienthaving an indwelling intraveneous catheter comprising: a luer valve, theluer valve being of the type configured to receive a luer lock connectorhaving a threaded shroud, the luer valve having a swabbable face forreceiving a male luer, the luer valve further having a proximal end withan externally threaded portion defining an ISO standard first diameterfor receiving a matching ISO standard internally threaded shroud of theluer lock connector adjacent the swabbable face, the luer valve furtherdefining a body portion proximal the externally threaded portion, thebody portion having an outer wall defining a second diameter greaterthan the first diameter; and a device for covering and protecting saidluer valve, said device comprising a sterile cover defining an openingsized for receiving the swabbable face, the externally threaded portion,and the body portion, the sterile cover being sized so that outer wallsof the sterile cover are forcibly dilated by the body portion when thesterile cover is mounted over the body portion so that the cover gripsthe outer wall of the body portion and is self-retaining upon the bodyportion, the sterile cover being further sized so that, in the mountedposition, the sterile cover is snugly retained over the swabbable face,the externally threaded portion, and the body portion, with the insidesurfaces of the outer walls of the sterile cover in gripping contactwith said outer wall of the body portion.
 5. The system of claim 4wherein the sterile cover is comprised of elastic material so that thedilation is opposed by elastic rebound.
 6. The system of claim 5 whereinthe sterile cover is configured so that elastic rebound secures thesterile cover to the body portion and retains the sterile cover over theluer valve.
 7. The system of claim 4 wherein the sterile cover isconfigured so that it has a flattened configuration when stored.
 8. Thesystem of claim 4 wherein at least a portion of the sterile cover iscomprised of fabric.
 9. The system of claim 4 wherein the sterile cover,adjacent the opening, is comprised of a soft elastomeric material whichis capable of dilating to accommodate a range of diameters so that thesterile cover is securely self-retaining upon a range of different luervalve body portions.
 10. The system of claim 4 wherein the sterile coveris comprised of an absorbent material and a water resistant material.11. The system of claim 4 wherein the sterile cover defines an innerpocket containing a disinfectant.
 12. The system device of claim 4wherein the sterile cover defines a wall and the wall provides areceiving portion for receiving one branch of a Y-site.
 13. The systemof claim 12 wherein the receiving portion comprises a slot for receivingat least a portion of the one branch of the Y-site.
 14. The systemaccording to claim 4 wherein the sterile cover is retained in a firstpackage, the device further comprising disinfectant within the firstpackage.
 15. The system according to claim 4 wherein the sterile coveris retained in a first package, the device further comprising a swabretained adjacent the sterile cover.
 16. The system according to claim15 further comprising a second package adjacent the first package andwherein the swab is contained within the second package.
 17. The systemaccording to claim 16 wherein the second package is mounted with thefirst package.
 18. The system according to claim 16 wherein the secondpackage is connected with the first package.
 19. The system according toclaim 16 further comprising a disinfectant along the sterile coverand/or the swab.
 20. The system according to claim 16 further comprisinga disinfectant along both the sterile cover and the swab, thedisinfectant along the sterile cover being a chemically differentdisinfectant than the disinfectant along the swab.